From March 2021, pharma firms marketing drugs will be held responsible for their quality

Currently, only the manufacturers are held liable under the Drugs and Cosmetics Act

Pharmaceutical companies that market drugs will now fall under the ambit of the Drugs and Cosmetics Act (DCA), according to a notification issued by the Ministry of Health and Family Welfare (MoHFW).

This means they will be held liable if the drug is found to be spurious, or its quality is deemed sub-standard. At present, only the manufacturer of the drug is held liable under the DCA.

Most pharma majors depute third-parties to produce drugs under ‘contract manufacturing’ deals. The pharma firms themselves, which market the drug, would lend the products their brand names, affixing their names on the packages for sale and distribution..

For example, Cipla markets a pack of 10 anti-acidity tablets, Pantosec (pantoprazole 40 mg). The company has deputed Pure & Cure Healthcare, a subsidiary of Haridwar-based Akums Drugs & Pharmaceuticals, to manufacture the drugs.

Regulatory compliances

“Any marketer who sells or distributes any drug shall be responsible for the quality of that drug as well as other regulatory compliances, along with the manufacturer, under these rules,” the latest notification states.

For drugs found to be sub-standard, the penalty involves three to five years of imprisonment. For those found to be spurious, the sentence could include life imprisonment. These clauses will apply to marketing firms too, come March 2021, when the amendments to the DCA take effect.

The Drug Controller General of India, in 2018, had mooted bringing marketing firms under the ambit of the law. Drug inspectors routinely collect samples of drugs from chemists and hospitals to run quality checks and upload the monthly reports of the results in the public domain.